The US Food and Drug Administration (FDA) granted Seattle Genetics’ (NASDAQ:SGEN) ADCETRIS treatment a Biologics License Application (BLA) on Thursday (August 17), and gave the gene therapy a priority review scheduled for December 16.
Jonathan Drachman, chief scientific officer of Seattle Genetics said the priority review status obtain is a “significant milestone” for the company to give ADCETRIS to patients with cutaneous T-cell lymphoma (CTCL). “We look forward to working with the FDA during the review of our application for ADCETRIS in CTCL, which, if approved, would be the fourth indication for this product,” Drachman said in a press release.
Designation made possible by data from previous trials
This approval comes from the data of a phase 3 ALCANZA trial alongside two phase 2 “investigator-sponsored” trials of ADCETRIS on patients with CTCL. The significant phase 3 trial reached its primary endpoint showing an improvement “in the rate of objective response lasting at least four months (ORR4) versus the control arm as assessed by an independent review facility,” according to Seattle Genetics. Drachman added data from the phase two trials also helped make the case for this designation from the FDA.
Seattle Genetics received a Breakthrough Therapy Designation from the FDA for ADCETRIS in treating patients with CD30-expressing mycosis fungoids and primary cutaneous anaplastic large cell lymphoma, who received a systemic therapy in the past.
The downsides displayed from the trailer for patients using ADCETRIS include anemia, peripheral sensory neuropathy, nausea, diarrhea, fatigue, and neutropenia.
Data from Zacks indicated the ADCETRIS was able to pull in $74.3 million in revenue for the second quarter of the year. “Seattle Genetics is also working on expanding the drug’s label which will be a further boost for the company’s revenues,” the publication wrote.
Interestingly enough, despite the positive news, the company’s stock saw a 1.70 percent decrease on Thursday. Seattle Genetics is currently valued at b$46.37 and its stock price has seen a 12.13 percent decline on a year-to-date period. Zacks currently has Seattle Genetics with a “Hold” designation. The company holds a “Moderate Buy” status from an analyst consensus on the data aggregator for stocks, TipRanks.
Don’t forget to follow @INN_LifeScience for real-time updates!
Securities Disclosure: I, Bryan Mc Govern, hold no direct investment interest in any company mentioned in this article.